subchondroplasty procedure in patients with bone marrow lesions

Conditions: Bone Marrow Lesions; Bone Marrow Edema

Summary: this is a prospective, multi-center, post-market data collection study intended to collect data on the short- and long-term safety and performance of the scp procedure.

patients with symptomatic bml(s) of the knee(s) who qualify for a scp procedure will be invited to participate. this study will enroll up to 95 patients across 4 investigative centers in europe over a period of 12 months. the maximum study duration is expected to be 6 years. follow-up assessments will be conducted at 1 month, 3, 6, 12-months and 24-months post injection; and subjects will be asked questions regarding their pain and functioning to further understand long-term outcomes. for all subjects at selected centers, a long standing x-ray and mri at screening and either at 12 months or 24 months will be obtained.

Eligibility criteria:
inclusion criteria: * at least 18 years of age at time of screening * patient with bml(s) in one or both knees, as diagnosed by the treating physician, willing and eligible to undergo the scp procedure * one or more bml(s) of the tibial plateau and/or femoral condyle extending to the articular surface of the joint confirmed on t2 weighted fat-suppressed or fat-suppressed proton density mr imaging by presence of white signal * patient's index knee alignment, which is defined radiographically, must be one of the following: neutral, 6 degree mechanical varus, or 6 degree mechanical valgus * patient is refractory to conservative non-surgical management of bml: * having failed 2 or more of the following: hyaluronic acid (ha) injection, corticosteroid injection, non-steroidal anti-inflammatory drugs (nsaids), physical therapy, bracing, or minimal surgical intervention (e.g. arthroscopy, debridement/chondroplasty, and/or loose body removal) * and diagnosis of bml is more than 3 months of the study treatment * willing and able to comply with the study procedures * signed an informed consent form approved by independent ethics committee (iec) exclusion criteria: * existing acute or chronic infections at the surgical site * bone in the index knee is non-viable or not capable of supporting and anchoring the implant. * known systemic disorders or any systemic inflammatory condition (e.g. rheumatoid arthritis) * acute traumatic injuries with open wounds close to the bone defect which are likely to become infected * known metabolic bone disease, including disorders in calcium metabolism * known immunologic abnormalities, including inflammatory bone disease * has a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years * diagnosis of patella-femoral joint oa and/or primarily patella-femoral symptoms * bml caused by acute trauma less than 3 months prior to enrollment * clinical and/or radiographic disease diagnosis of the index knee that includes any of the following: * kellgren-lawrence grade 4 osteoarthritis (oa) * bml located at anterior cruciate ligament (acl)/ posterior cruciate ligament (pcl) insertion * any major or cartilage repair or alignment surgery (i.e. osteotomy, autograft, scaffold, marrow stimulation, debridement, all cell-based therapies, etc.) of the index knee within 12 months prior to enrollment * pregnant at time of injection * lactating at time of injection * use of any investigational drug or device within 30 days prior to enrollment * use of any investigational biologics within 30 days prior to enrollment

Keywords: accufill injectable calcium phosphate subchondroplasty